Magnesium Oxide in Treating Hot Flashes in Menopausal Women With Cancer

Breast Cancer Clinical Trial

Official title: A Pilot Phase II Trial of Magnesium Supplements to Reduce Menopausal Hot Flashes in Cancer Patients

Status Completed

Clinical Trial Summary

RATIONALE: Magnesium oxide may help relieve hot flashes in women with cancer.

PURPOSE: This phase II trial is studying how well magnesium oxide works in treating hot flashes in menopausal women with cancer.

Clinical Trial Description

OBJECTIVES:

Primary

• To determine if magnesium oxide supplement will decrease the frequency and severity of hot flashes by 50% in menopausal women with cancer.

Secondary

• To evaluate the effect of magnesium oxide on overall quality of life.

• To evaluate the toxicities of magnesium oxide when administered at commonly used supplement doses.

OUTLINE: Patients receive oral magnesium oxide once daily in weeks 2-5. Patients whose hot flashes are not satisfactorily controlled after 2 weeks of treatment may receive magnesium oxide twice daily in weeks 4 and 5.

Patients complete a daily hot flash diary for 5 weeks beginning 1 week before treatment. Patients also complete quality-of-life, symptom, and self-assessment questionnaires at baseline, once weekly during treatment, and at the completion of treatment.

After completion of study treatment, patients are followed up for at least 30 days. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Cancer Survivor
• Hot Flashes
• Unspecified Adult Solid Tumor, Protocol Specific

• NCT number: NCT01008904
• Study type: Interventional
• Source: Virginia Commonwealth University
• Status: Completed
• Phase: Phase 2
• Start date: July 2009
• Completion date: March 2013